Office of Global Policy and Strategy

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The FDA’s Office of Global Policy and Strategy (OGPS) manages the agency’s foreign offices in China, Europe (Belgium, the Netherlands, United Kingdom), India, Latin America (Costa Rica, Chile, Mexico), and African Medicines Agency Liaison Office in Rwanda. These offices are strategically located to strengthen the agency’s ability to perform inspections and lead regulatory cooperation initiatives including harmonization. 

 

OGPS also serves as a point of contact for many of the FDA’s bilateral and multilateral interactions and is the agency lead for negotiating arrangements including mutual recognition agreements, confidentiality commitments, trade instruments, and statements of cooperation. OGPS promotes and protects the public health of Americans by ensuring global considerations are fully integrated into FDA policies and operational activities. 

 

• Through policy coherence: OGPS promotes mutually reinforcing policy actions to advance the FDA’s public health and regulatory interests globally.
• Through the development of global partnerships: OGPS partnerships will improve compliance with FDA requirements, enhance the capacity of foreign regulatory partners to conduct inspections and laboratory analyses, increase global understanding of the links between strong, well-functioning regulatory systems and public health, economic development, and global trade in goods.
• Through the collection, analysis and sharing of high-quality information -- including inspection data – to advance the FDA’s public health mission. OGPS activities will enhance our risk-based management of regulatory resources, improve our oversight, increase our understanding of complex global supply chains and their effects on the safety and quality of products we regulate, and strengthen capacity to detect and remove violative products and mitigate public health risks through regulatory actions.

OPGS Activities

• From a Global Perspective - Occasional thought pieces on international topics from FDA experts across the agency
• Global Updates - Offers readers news, information, events, and resources from the FDA's OGPS headquarters and foreign offices
• International Arrangements
• International Programs and Activities
• International Publications, Speeches, and News

Recalls and Alerts

• FDA Recalls, Market Withdrawals
• Imports and Exports

Resources For You

• FDA-TRACK
• FDA Globalization
• Imports and Exports
• Partnerships and Collaboration

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